Evidence map›Paper›PMID 35483886›Full record

Trial reportGut2022

Diet or medication in primary care patients with IBS: the DOMINO study - a randomised trial supported by the Belgian Health Care Knowledge Centre (KCE Trials Programme) and the Rome Foundation Research Institute.

Florencia Carbone, Karen Van den Houte, Linde Besard, Céline Tack, Joris Arts, Philip Caenepeel, Hubert Piessevaux, Alain Vandenberghe, Christophe Matthys, Jessica Biesiekierski and 17 more

Registry-linked trialOpen access · hybridAbstract readRandomized Controlled Trial
In one paragraph

Trial report in Gut, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04270487 (A Randomized Controlled Trial to Evaluate the Short-term Efficacy and Long-term Health Economic Impact of a Dietary Intervention Compared to Pharmacotherapy With a Musculotropic Spasmolytic Agent for Newly Diagnosed or Newly Treated Irritable Bowel Syndrome in Primary Care), which is not on this map. Cited by 30 papers.

0numbers the graph read from it
0cells of the map it votes in
30citing papers in PubMed
9.6field-weighted citation impact, top 1% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT04270487 phase4completednot on this map

A Randomized Controlled Trial to Evaluate the Short-term Efficacy and Long-term Health Economic Impact of a Dietary Intervention Compared to Pharmacotherapy With a Musculotropic Spasmolytic Agent for Newly Diagnosed or Newly Treated Irritable Bowel Syndrome in Primary Care

TypeinterventionalSponsorUniversitaire Ziekenhuizen KU LeuvenRan2018 to 2020Enrolled472ConditionsIrritable Bowel SyndromeArmsIBS Diet, Otilonium Bromide
3 · Its place in the literature

Who cites it

30 citing papers in PubMed, 60 citations in OpenAlex.

  1. Trial
  2. Trial
  3. Review
  4. Article
  5. Article
  6. Review
  7. Article
  8. Article
  9. Expert Opinion on the Efficacy and Safety of Antispasmodics with a Focus on Irritable Bowel Syndrome.The Turkish journal of gastroenterology : the official journal of Turkish Society of Gastroenterology · 2025
    Review
  10. Review
  11. Repurposing 1,4-Dihydropyridine Scaffold: 4-Imidazo[2,1-Pharmaceuticals (Basel, Switzerland) · 2025
    Article
  12. Article
  13. The Duodenal Microenvironment in Functional Dyspepsia.Journal of neurogastroenterology and motility · 2025
    Review
  14. [Dietary Therapy in Irritable Bowel Syndrome].The Korean journal of gastroenterology = Taehan Sohwagi Hakhoe chi · 2025
    Review
  15. Article
  16. Article
  17. Review
  18. Review
  19. Review
  20. DOMINO trialTherapeutic advances in gastroenterology · 2024
    Article
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

27 authors at 6 institutions in 3 countries.

Florencia CarboneDepartment of Gastroenterology, KU Leuven University Hospitals Leuven, Leuven, Belgium.
Karen Van den HouteTARGID (Translational Research Center for Gastrointestinal Disorders), KU Leuven, Leuven, Belgium.
Linde BesardDepartment of Gastroenterology, KU Leuven University Hospitals Leuven, Leuven, Belgium.
Céline TackDepartment of Gastroenterology, KU Leuven University Hospitals Leuven, Leuven, Belgium.
Joris ArtsDepartment of Gastroenterology, KU Leuven University Hospitals Leuven, Leuven, Belgium.
Philip CaenepeelDepartment of Gastroenterology, KU Leuven University Hospitals Leuven, Leuven, Belgium.
Hubert PiessevauxDepartment of Gastroenterology and Hepatology, Université catholique de Louvain, Louvain-la-Neuve, Belgium.
Alain VandenbergheMedical Research Laboratories International, Chaumont-Gistoux, Belgium.
Christophe MatthysClinical and Experimental Endocrinology, Katholieke Universiteit Leuven, Leuven, Belgium.
Jessica BiesiekierskiTARGID (Translational Research Center for Gastrointestinal Disorders), KU Leuven, Leuven, Belgium.
Luc CapiauPrimary care physician, Domino primary care physician study group, Leuven, Belgium.
Steven CeulemansPrimary care physician, Domino primary care physician study group, Leuven, Belgium.
Olivier GernayPrimary care physician, Domino primary care physician study group, Leuven, Belgium.
Lydia JonesPrimary care physician, Domino primary care physician study group, Leuven, Belgium.
Sophie MaesPrimary care physician, Domino primary care physician study group, Leuven, Belgium.
Christian PeetermansPrimary care physician, Domino primary care physician study group, Leuven, Belgium.
Willem RaatDepartment of Public Health and Primary Care, KU Leuven, Leuven, Belgium.
Jeroen StubbePrimary care physician, Domino primary care physician study group, Leuven, Belgium.
Rudy Van BoxstaelPrimary care physician, Domino primary care physician study group, Leuven, Belgium.
Olivia VandeputPrimary care physician, Domino primary care physician study group, Leuven, Belgium.
Sophie Van SteenbergenPrimary care physician, Domino primary care physician study group, Leuven, Belgium.
Lukas Van OudenhoveTARGID (Translational Research Center for Gastrointestinal Disorders), KU Leuven, Leuven, Belgium.
Tim VanuytselDepartment of Gastroenterology, KU Leuven University Hospitals Leuven, Leuven, Belgium.
Michael JonesFaculty of Medicine, Health and Human Sciences, Macquarie University, Sydney, New South Wales, Australia.
Jan TackDepartment of Gastroenterology, KU Leuven University Hospitals Leuven, Leuven, Belgium jan.tack@med.kuleuven.ac.be.ORCID 0000-0002-3206-6704
DOMINO Study Collaborators
Domino Study Collaborators
KU Leuven · BEZiekenhuis Oost-Limburg · BELa Trobe University · AUMacquarie University · AURome Foundation · USUCLouvain · BE

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundIn Europe, IBS is commonly treated with musculotropic spasmolytics (eg, otilonium bromide, OB). In tertiary care, a low fermentable oligosaccharides, disaccharides, monosaccharides and polyols (FODMAP) diet provides significant improvement. Yet, dietary treatment remains to be explored in primary care. We evaluated the effect of a smartphone FODMAP-lowering diet application versus OB on symptoms in primary care IBS.

methodsIBS patients, recruited by primary care physicians, were randomised to 8 weeks of OB (40 mg three times a day) or diet and followed for 24 weeks. We compared IBS Symptom Severity Score and the proportion of responders (improvement ≥50 points) in all patients and the subgroup fulfilling Rome IV criteria (Rome+). We also evaluated treatment efficacy, quality of life, anxiety, depression, somatic symptom severity (Patient Health Questionnaire (PHQ15, PHQ9)) and treatment adherence and analysed predictors of response.

results459 primary care IBS patients (41±15 years, 76% female, 70% Rome+) were randomised. The responder rate after 8 weeks was significantly higher with diet compared with OB (71% (155/218) vs 61% (133/217), p=0.03) and more pronounced in Rome+ (77% (118/153) vs 62% (98/158), p=0.004). Patients allocated to diet (199/212) were 94% adherent compared with 73% with OB (148/202) (p<0.001). The significantly higher response rate with diet was already observed after 4 weeks (62% (132/213) vs 51% (110/215), p=0.02) and a high symptom response persisted during follow-up. Predictors of response were female gender (OR=2.08, p=0.04) for diet and PHQ15 (OR=1.10, p=0.02) for OB.

conclusionIn primary care IBS patients, a FODMAP-lowering diet application was superior to a spasmolytic agent in improving IBS symptoms. A FODMAP-lowering diet should be considered the first-line treatment for IBS in primary care. TRIAL REGISTRATION NUMBER: NCT04270487.

Indexed as

Irritable Bowel SyndromeAcademies and InstitutesBelgiumDelivery of Health CareDietDisaccharidesFemaleFermentationHumansMaleMonosaccharidesOligosaccharidesParasympatholyticsPrimary Health CareQuality of LifeRomeDisaccharidesMonosaccharidesOligosaccharidesParasympatholyticsIRRITABLE BOWEL SYNDROMEPRIMARY CAREQUALITY OF LIFE

Identifiers

PMID35483886
PMCPMC9554021
OpenAlexW4225113130

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.